BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3962721 · Received June 23, 2014

    Report

    Report Number
    1720753-2014-05296
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE CANDLESTICKS WERE WAS EVALUATED AND REGREASED. A COMPLETE FILAMENT CALIBRATION WAS PERFORMED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM HAD GENERATOR ERROR MESSAGE. THIS ERROR CAUSES THE SYSTEM TO SHUT DOWN, RESULTING IN A LOSS IF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364646 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1